Module 15 Presentations

15/04/2024

Comparing Benefit vs. Risk in Clinical Evaluation

• From EU MDR Regulation : … analysis of all assessments of benefit and risk of possible relevance for the use of the device for the intended purpose, when used in accordance with the intended purpose given by the manufacture …

Contrast t o US FDA

Establish at Clinical Trials

Benefit / Risk Ratio

Benefit / Risk Ratio

Market Use of Device / Life-Time of Device

Does it Change Over Time?

Baseline Clinical Trials / Market Introduction

The Organisation for Professionals in Regulatory Affairs

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Statutory Standard for Safety and Effectiveness

Clinical Study= Yes

PMA Applications – high risk devices

PMA applications must provide: “reasonable assurance of safety and effectiveness” by “weighing any probable benefit to health from the use of the device against any probable risk of injury or illness from such use” PMA sponsors submit valid scientific evidence , including one or more clinical investigations where appropriate, which FDA reviews to determine whether “the device will have the effect it purports or is represented to have under the conditions of use prescribed, recommended, or suggested in the labeling of the device” Review clinical data submitted as part of the PMA application and determine • Clinical data support claims made by the sponsor concerning clinically significant results from the device according to its indications for use/intended use • Data analysis demonstrates probable benefits of the device outweigh its probable risks • Supported also with nonclinical safety and efficacy data (bench performance testing)

The Organisation for Professionals in Regulatory Affairs

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